Universal AdhesiveNCT05054673
Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients
A study testing universal adhesive in people with Universal Adhesive, run by Cairo University.
Trial summary
the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Universal Adhesive
- What is being tested?
- universal adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient had to be in good general health
- Geriatric patients
- Have an acceptable oral hygiene level
- Class V cavities in anterior and posterior teeth
- Males \& females included
- Anticipated availability for recalls (6 months and 12 months) through the 1-year study period
Who cannot join
- Lack of written informed consent to participate
- Poor oral hygiene,
- Severe bruxism
- Severe or chronic periodontitis
- Allergies to components of the materials used
- Underage patients
- Non vital pulp
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)
the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.
- Conditions
- Universal Adhesive
- Being tested
- universal adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal adhesiveOther
PALFIQUE universal adhesive
universal adhesiveOther
3M™ ESPE™ single bond Universal Adhesive
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive) Receives: Other: universal adhesive |
| control | Active comparator | 3M™ ESPE™ single bond Universal Adhesive Receives: Other: universal adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Marginal adaptation
modified USPHS criteria, ordinal
Measured: 1 year
Secondary outcomes (4)
level of Retention
binary , modified USPHS criteria
Measured: 1 year
Level of Marginal discoloration
ordinal, modified USPHS criteria
Measured: 1 year
Rate of Secondary caries
binary , modified USPHS criteria
Measured: 1 year
level of Postoperative sensitivity
binary , modified USPHS criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study startNov 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Universal AdhesiveStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maysaa Mahmoud Mostafa Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054673
- Sponsor's protocol ID
- palfique bond
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05054673
- Acronym / sponsor ID
- palfique bond
- Conditions
- Universal Adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: universal adhesivePALFIQUE universal adhesive (Tokuyama self-cure universal adhesive) |
| control | Active comparator | Other: universal adhesive3M™ ESPE™ single bond Universal Adhesive |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient had to be in good general health
- Geriatric patients
- Have an acceptable oral hygiene level
- Class V cavities in anterior and posterior teeth
- Males \& females included
Key exclusion criteria (7 listed)
- Lack of written informed consent to participate
- Poor oral hygiene,
- Severe bruxism
- Severe or chronic periodontitis
- Allergies to components of the materials used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| universal adhesivePALFIQUE universal adhesive | Other | intervention |
| universal adhesive3M™ ESPE™ single bond Universal Adhesive | Other | control |
Primary outcome
Measuring the Marginal adaptation
Time frame: 1 year
modified USPHS criteria, ordinal
4 secondary outcomes
level of Retention
Time frame: 1 year
Level of Marginal discoloration
Time frame: 1 year
Rate of Secondary caries
Time frame: 1 year
level of Postoperative sensitivity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Healthy Participant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing universal adhesive in people with Universal Adhesive, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maysaa M Mostafa, B.D.S. (01001422220 ext. 002, mayssaa.motafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the Marginal adaptation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.